Field of the Invention
The present invention generally relates to formulations that provide support to an individual's body during vaccinations and adaptive immune and methods thereof. More specifically, the present invention is drawn to formulations that comprise novel combinations of ingredients that target epigenetic regulation of gene expression, specific enzymatic reactions, cytokine differentiation and immune system homeostasis in various metabolic pathways in an individual during vaccination and adaptive immune system response. The administration of the formulation may improve antibody response and decrease vaccine side effects to provide and safer and more effective vaccinations for the population at large by improving the synthesis and release of cellular biomakers.
Background
The mitochondrion is known to function as the powerhouse of the cell because it produces the energy that an individual's body requires to survive. However, in this process of energy production, it produces reactive oxygen species that are harmful to the body. Glutathione is a primary antioxidant that protects the body from the harmful effects of reactive oxygen species such as free radicals, heavy metals and peroxides. Glutathione is a tripeptide made up of three amino acids (glutamate, glycine and cysteine). Cysteine, which is the rate limiting factor in glutathione synthesis can either be made in the cell by a process called transulfuration or can be obtained from outside the cell, for instance, from diet or through nutrient support.
Glutathione exists in two forms, including reduced glutathione (GSH) and the non-reactive, oxidized form (glutathione disulfide form; GSSG) depending on the amount of electrons it carries. Glutathione is in a reactive state when it is reduced (GSH) and in a non-reactive state when it is oxidized (GSSG). Reduced glutathione (GSH) gives up an electron, and thus becomes reactive, but then readily bonds with another oxidative glutathione molecule to form non-reactive glutathione disulfide (GSSG). GSSG is a disulfide formed from the bonding of two oxidative glutathione molecules. The bonding neutralizes the two oxidative glutathione molecules. Due to the rapid nature of the reduction of the oxidized form of glutathione relative to its synthesis or secretion, the ratio of reduced glutathione to oxidized glutathione is a good indicator of the oxidative stress within cells.
Oxidative stress is important for reasons including but not limited to its ability to inhibit methylation. However, methylation is very essential as it is involved in the single carbon transfer of molecules. Defects in single carbon transfer are associated with many different diseases and cellular dysfunction. One of the most essential methylation reactions involves DNA, histone and specific CpG island methylation, which has implications with regard to gene expression, cytokine differentiation and immune regulation. Methylation is also involved in certain enzymatic pathways and bodily functions that include but are not limited to creatine and adenosine synthesis (energy production), phospholipid synthesis (cellular membrane integrity), serotonin and melatonin production, biopterin (BH4) synthesis (amino acid metabolism), glutathione synthesis, arginine metabolism (nitrous oxide synthesis), catecholamine production (cognitive status), and CpG island methylation for adequate production of interferon gamma for immune system homeostasis. Thus, disruption of methylation equilibrium plays a critical role in global disease states and may play a role in vaccine response.
Conventional methods and formulations lack the ability to beneficially target gene expression for proper enzymatic reactions involved in metabolic pathways, in vaccine response and in adaptive immune response including but not limited to those involved in maintaining the delicate balance between methylation, transsulfuration, and oxidative stress for healthy cellular metabolism. Further, there is a current lack of focus on the mechanisms that cause individuals to respond or not respond to standard vaccine protocols. Thus, there is a long-felt but significant and un-met need in the art for formulations and methods that can beneficially target such enzymatic reactions, and help essentially maintain the delicate balance between methylation, transsulfuration, and oxidative stress—or a combination thereof to improve vaccine response and reduce vaccine side effects. Still further, there is a long-felt and significant but un-met need in the art of supportive immunization protocols that can target epigenetic expression, enzymatic kinetics and immune system homeostasis to improve vaccine response and reduce side effects. The present invention satisfies this long standing need in the art.